Acute Respiratory Failure With Hypoxia Clinical Trial
— RESTOfficial title:
pRotective vEntilation With Veno-venouS Lung assisT in Respiratory Failure
Verified date | March 2022 |
Source | Belfast Health and Social Care Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether veno-venous extracorporeal carbon dioxide removal (VV-ECCO2R) and lower tidal volume mechanical ventilation improves outcomes and is cost-effective, in comparison with standard care in patients who are mechanically ventilated for acute hypoxaemic respiratory failure
Status | Active, not recruiting |
Enrollment | 1120 |
Est. completion date | April 30, 2022 |
Est. primary completion date | March 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Invasive mechanical ventilation using positive end expiratory pressure (PEEP) = 5cmH2O - Acute and potentially reversible cause of acute respiratory failure as determined by the treating physician - Within 48 hours of the onset of hypoxemia as defined by Pa02/Fi02 less than or equal to 20kPA Exclusion Criteria: - Age < 16 years old - Intubated and mechanically ventilated via an endotracheal or tracheostomy tube = 7 days (168 hours) up to the time of randomisation - Ability to maintain Vt to = 3ml/kg PBW while maintaining pH = 7.2 as determined by the treating physician - Receiving, or decision to commence, ECMO in the next 24 hours - Mechanical ventilation using high frequency oscillation ventilation or airway pressure release ventilation - Untreated pulmonary embolism, pleural effusion or pneumothorax as the primary cause of acute respiratory failure - Acute respiratory failure fully explained by left ventricular failure or fluid overload (May be determined by clinical assessment or echocardiography/cardiac output monitoring) - Left ventricular failure requiring mechanical support - Contra-indication to limited systemic anticoagulation with heparin - Unable to obtain vascular access to a central vein (internal jugular or femoral vein) - Consent declined - Treatment withdrawal imminent within 24 hours - Patients not expected to survive 90 days on basis of premorbid health status - DNAR (Do Not Attempt Resuscitation) order (excluding advance directives) in place - Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing) - Severe chronic liver disease (Child Pugh >11) - Platelet count < 40,000 mm3 (Prior to catheter insertion) - Previously enrolled in the REST trial - Prisoners |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Belfast Health and Social Care Trust | Northern Ireland Clinical Trials Unit, Queen's University, Belfast |
United Kingdom,
Acute Respiratory Distress Syndrome Network, Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. — View Citation
Bein T, Weber-Carstens S, Goldmann A, Müller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy (˜3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10. — View Citation
Fitzgerald M, Millar J, Blackwood B, Davies A, Brett SJ, McAuley DF, McNamee JJ. Extracorporeal carbon dioxide removal for patients with acute respiratory failure secondary to the acute respiratory distress syndrome: a systematic review. Crit Care. 2014 May 15;18(3):222. doi: 10.1186/cc13875. Review. — View Citation
Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Right Ventricular function | Change in tricuspid annular plane systolic excursion (TAPSE) in cm at day 2 or 3 from randomisation measured with echocardiography | Baseline & Day 2/Day 3 | |
Primary | All cause mortality | 90 days after randomisation | ||
Secondary | Tidal volume (ml/kg Predicted Body Weight) | day 2 and day 3 after randomisation | ||
Secondary | Ventilator free days | 28 days after randomisation | ||
Secondary | Duration of ventilation in survivors | 28 days after randomisation | ||
Secondary | Need for Extracorporeal Membrane Oxygenation (ECMO) | 7 days after randomisation | ||
Secondary | Mortality rate | 28 days, 6 months and 1 year after randomisation | ||
Secondary | Health Related Quality of Life | 6 months and 1 year after randomisation | ||
Secondary | Adverse Event Rate | 28 days | ||
Secondary | Health & Social Care Service costs | 6 months and 1 year after randomisation | ||
Secondary | St George Respiratory Questionnaire | 1 year after randomisation | ||
Secondary | Need for home oxygen | 6 months and 1 year after randomisation | ||
Secondary | Post Traumatic Stress Syndrome Questionnaire (PTSS-14) | 1 year after randomisation | ||
Secondary | Montreal Cognitive Assessment (MoCA-BLIND) or AD8 Dementia Screening Interview (AD8) | 1 year after randomisation |
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